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Sonographic and Laboratory Evaluation of the Thyroid Gland in Patients With Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT01270425
Recruitment Status : Completed
First Posted : January 5, 2011
Last Update Posted : February 28, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

Study Description
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

Systemic sclerosis (SSc) is a systemic disease that involves various organs such as the skin, kidneys, gastrointestinal tract and lungs. Dysfunction of the thyroid gland is prevalent in these patients and may be related to thyroid fibrosis or to thyroid autoimmune disease, i.e. hashimoto's thyroiditis. Thyroid nodules are prevalent in the general population, although some reports suggest they might be more frequent in patients with SSc. Hashimoto's thyroiditis, by itself, carries a higher risk for thyroid nodules and thyroid cancer.

The aim of the study:To characterize sonographycally the thyroid gland of patients with SSc with and without Hashimoto's disease


Condition or disease
Systemic Sclerosis Hashimoto Thyroiditis Thyroid Nodules

Detailed Description:
The study protocol Fifty patients with SSc according to the current international classification will be included in the study. The patients, followed-up regularly in an out-patient clinic, will be tested for their thyroid function tests as well as the presence of thyroid auto antibodies. Clinical data will be collected from their medical records. Ultrasonographic examination of the thyroid gland will be performed by a single examiner. The gland will be characterized in detail with regards to its size and echotexture and cervical lymph nodes will be detected. The number and size of its nodules will be described as well as their echoic pattern (iso, hyperechoic or hypoechoic) calcifications (micro and macro), and borders status. Large nodules (≥ 1 cm in diameter) or with malignancy- associated characteristics will be aspirated according to current clinical practice. Treatment will be given according to the cytology diagnosis. Thyroid hormone supplementation will be recommended when thyrotropin level >8 mIU/L or according to clinical judgment of the investigators.

Study Design
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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sonographic Characterization of the Thyroid Gland in Patients With Systemic Sclerosis With and Without Hashimoto Thyroiditis
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid
U.S. FDA Resources

Groups and Cohorts
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. There are no spesific outcome measures from trail [ Time Frame: Nnone ]
    the measures from trail are equal to vast population


Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with SSc according to the current international classification
Criteria

Inclusion Criteria:

  • Clinical diagnosis of systemic sclerosis

Exclusion Criteria:

  • non
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01270425


Locations
Israel
Meir Medical Center
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Pnina Rotman-Pikielny, MD Meir Medical Center, Israel
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01270425     History of Changes
Other Study ID Numbers: MMC11175-10CTIL
First Posted: January 5, 2011    Key Record Dates
Last Update Posted: February 28, 2013
Last Verified: March 2012

Keywords provided by Meir Medical Center:
systemic sclerosis
hashimoto thyroiditis
thyroid nodules

Additional relevant MeSH terms:
Sclerosis
Thyroid Diseases
Scleroderma, Systemic
Scleroderma, Diffuse
Thyroid Nodule
Thyroiditis
Hashimoto Disease
Pathologic Processes
Endocrine System Diseases
 Connective Tissue Diseases
Skin Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Thyroiditis, Autoimmune